National Institutes of Health (NIH) clinical research networks were developed to increase the efficiency and speed of clinical research. HJFMRI supports partner sites in Africa chosen participate as clinical trial units in several of these NIH networks due to the sites' rigorous standards and proven ability to overcome technical research challenges.
HJFMRI supports sites in Africa that have been part of the National Institutes of Health HIV Vaccine Trial Networks (HVTN) and AIDS Clinical Trial Group (ACTG) clinical research networks since 2008. Sites in these networks conduct groundbreaking research to improve HIV vaccine, prevention, and treatment products under leadership of HJFMRI's research partner, the U.S. Military HIV Research Program (MHRP) at the Walter Reed Army Institute of Research.
Participation in ACTG and HVTN networks allows partner sites to build upon existing current clinical research infrastructure to create a broader, more flexible, and more collaborative approach to global HIV/AIDS research priorities. Sites have helped conduct many high-priority therapeutics studies under the ACTG, including OCTANE (Prevention of Mother-to-Child Transmission) and STRIDE (tuberculosis). Under the HVTN, sites have participated in large, high-profile trials for HIV vaccines (HVTN 705/HVTN 706) and novel prevention strategies such as antibody mediated prevention (AMP, HVTN 703).
Since 2015, HJFMRI has been supporting the execution of HIV Prevention Trials Network (HPTN) studies in Kenya in partnership with the Kenya Medical Research Institute’s (KEMRI) Centre for Global Health Research (CGHR) to contribute to this critical effort. This work is sponsored by the U.S. Centers for Disease Control and Prevention.
Building on their successful participation in HVTN, HJFMRI sites have been able to pivot to conduct COVID-19 vaccine and therapeutic clinical trials as part of the NIH COVID-19 Prevention Trials Network (CoVPN). The CoVPN leverages the infectious disease expertise of existing research networks and global partners to address the pressing need for vaccines and antibodies against SARS-CoV-2. As part of the CoVPN network, HJFMRI will participate in work to develop and conduct studies to ensure rapid and thorough evaluation of vaccines and antibodies for the prevention of COVID-19. Sites in Kenya are currently preparing to take part in CoVPN 3005, a Phase 3 trial of Sanofi's recombinant DNA COVID-19 vaccine candidate, and the CoVPN 3008 UBUNTU study, a Phase 3 trial of Moderna's mRNA vaccine.
CASE STUDY: The Global Challenge of COVID-19
The SARS-CoV-2 pandemic has reinforced the need for robust disease surveillance networks, rapid outbreak response capabilities, and a growing need for additional training to prepare for infectious disease outbreak threats.